Impact of mHealth in Heart Transplant Management

Heart Transplant Clinical Trial

— mHeart  

Official title:

Effectiveness Improving Medication Adherence in Heart Transplant Management

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02554578
• Other study ID #: IIBSP-MHE-2014-55
• Status: Active, not recruiting
• Phase: N/A
• First received: September 15, 2015
• Last updated: August 22, 2016
• Start date: October 2015

Study information

• Verified date: August 2016
• Source: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to improve medication adherence, engagement and support to heart transplant patients through implementation of a new clinical care programme conducted by the clinical pharmacy service in cooperation with the heart transplant team and supported by mobile health (mHealth).

Description:

Non-adherence to immunosuppressive medications generally ranges from 20-40% and is associated with acute rejection episodes and graft loss. Many solid organ transplant centres have incorporated transplant pharmacists into the multidisciplinary transplant clinical team focused on improving outcomes and safety associated with drug therapy.

Mobile technology has undergone rapid advances in the past several years and the use of mHealth in pharmaceutical care is changing pharmacy practice. Several published reports have identified general mobile applications suited for improve adherence. But evidence supporting the benefits in clinical practice is limited.

This study expects to analyse the potential of mHealth to improve medication adherence and heart transplant patient management in real clinical practice.

The investigators asses a new multidisciplinary follow-up programme in heart transplant recipients supported by mobile health (mHealth) with the aim to improve medication adherence, prevent drug related problems and improve patient clinical outcomes.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 158
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Heart transplant patients = 18 years of age

• Give informed consent.

• Be able to use a mobile device (smartphone).

• Sign a confidentiality agreement (interventional group).

Exclusion Criteria:

• Do not meet all the inclusion criteria.

• Non-available to receive a minimum of one-year clinical follow-up by the heart transplant unit.

• Suffer severe mental disorders, other mental pathologies or conditions that can be a barrier to use the mobile application

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heart Transplant

Intervention

Other:
• Multidisciplinary follow-up programme supported by mHealth
The follow-up programme integrates an online health platform (app and web) to monitor patients remotely, into the multidisciplinary team workflow, in order to improve heart transplant management. Patients will use the mobile application designed to help them to manage their health issues and facilitate communication with the transplant team. Data recorded manually by the patient using the mHealth application include pharmacotherapeutic information (medication adherence, barriers to adherence, side effects, interactions, etc.), clinical symptoms and other relevant clinical information (blood pressure, cardiac frequency, exercise, glucose level, diet, mood, etc.). mHealth will be used by the transplant team as a complementary way of deliver patient care. Analysis of the data collected by the multidisciplinary team may help to prioritise and provide personalized pharmacotherapeutic and medical interventions to patients and their families.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Medication adherence measured on validated scales and questionnaires	Change From Baseline in Medication Adherence on the Simplified Medication Adherence Questionnaire (SMAQ)	6 months	No